MAUDE Adverse Event Report: COVIDIEN BTK TURBOHAWK; CATHETER, PERIPHERAL, ATHERECTOMY

Catalog Number THS-SX-C

Device Problems Entrapment of Device (1212); Difficult to Open or Close (2921)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/01/2015

Event Type  malfunction  

Event Description

It is reported that the physician was intending to use a turbohawk device to treat an unknown lesion.It was reported that the customer was unable to open or close the cutter.Another sx-c was used to complete the procedure.No patient injury was reported.Evaluation summary: the device was received for evaluation.The cutter head was advanced within the distal assembly.Biological material was visible within the cutter window.The cutter was unable to be pulled back upon the first attempt of retracting the thumb switch.The turbohawk was attached to a cutter driver from the lab and retracted.Metal struts were discovered wrapped around the cutter, proximal to the cutter blade.These metal struts prevented the cutter blade from being completely retracted.These metal struts were consistent with struts from a stent implanted previous to the procedure performed with the turbohawk.

• Brand Name: BTK TURBOHAWK
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 5705382
• MDR Text Key: 46777986
• Report Number: 2183870-2016-00381
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103618
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/20/2018
• Device Catalogue Number: THS-SX-C
• Device Lot Number: A093404
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2016
• Date Manufacturer Received: 05/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/22/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1